New England Compounding has been investigated by state and federal regulators several times, in some cases for overstepping its bounds as a compounding pharmacy and venturing into manufacturing. The FDA received three complaints about the company in 2002 and 2003 involving its preparation of methylprednisolone acetate, one of the complaints concerned lapses in sterile procedures, leading to investigations by the state and the FDA, said Massachusetts health officials.
A complaint this year about the potency of eye medications remains under investigation.
During an inspection in fall 2004, the FDA found numerous problems at the company, which were detailed in a 2006 warning letter.
The agency said that “like a manufacturer,’’ the company developed an anesthetic drug called Extra Strength Triple Anesthetic cream, for which it generated “sales by giving physicians ‘courtesy prescriptions’ (i.e., free samples). These actions are not consistent with the traditional practice of pharmacy compounding,” the FDA warned. Compounders produce “reasonable quantities of drugs upon receipt of valid prescriptions from licensed practitioners to meet the unique needs of individual patients,’’ the agency said.
Yet, the company apparently continued to ship large orders.
“Based on the quantity and the distribution into 23-plus states, we are struggling as an organization to understand how that volume could have corresponding prescriptions associated with’’ the drugs, Miller said. “The board of pharmacy is supposed to decide if they crossed the line.’’
The company declined to answer questions about its practices Friday.
Rules vary by state, but if compounding pharmacies meet certain conditions, they are allowed to sell to out-of-state providers, said Eric Kastango, a pharmacist and consultant.
But the problem, he said, is that many state inspectors don’t have the expertise the FDA possesses. “They may not understand the nuances and details of sterile compounding operations,’’ said Kastango, who is a member of the United States Pharmacopeial Convention, a nonprofit organization that publishes standards for pharmacies. He said he was not speaking on behalf of the group.
But, Kastango said, the FDA also has struggled with how to regulate compounding pharmacies, which are not held to the same safety standards as the pharmaceutical industry.
The FDA would not comment Friday about regulatory challenges. The Massachusetts Department of Public Health released a statement that said pharmacists and pharmacies are “only permitted to dispense and compound medication pursuant to a prescription from a registered practitioner for an individual patient.”
The department — which oversees the Massachusetts Board of Registration in Pharmacy, the entity that licenses compounders — did not respond to requests from the Globe for an explanation of why New England Compounding had been allowed to ship thousands of vials of medications nationwide, if it was licensed only to prepare medications for individual patients or providers.
The department said in a statement that “all matters concerning [New England Compounding] drug compounding and distribution remain under investigation by federal authorities and [the health department] at this time.”
Liz Kowalczyk can be reached at firstname.lastname@example.org. Kay Lazar can be reached at email@example.com.